NCT05168176

Bioequivalence of Dotilavir Sodium Tablets in Healthy Subjects in the Fasting and Fed State

Bioequivalence of Dotilavir Sodium Tablets in Healthy Subjects: A Single-center, Open, Randomized, Single-dose, Crossover Study

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: The Affiliated Hospital of Qingdao University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The primary purpose of this study is to evaluate the bioequivalence of two dotilavir sodium tablets in the fasting and fed state. The secondary purpose of this study is to observe the safety of the test and reference preparations. An open-label, randomized, single-dose, crossover study in healthy Chinese volunteers was performed. A single oral dose of 50 mg of two dotilavir sodium tablets was administered to 64 healthy volunteers, with 36 in the fasted group and 28 consuming a high-fat diet. The evaluated pharmacokinetic parameters, including maximum concentration (Cmax), the area under the concentration-time curve (AUC0-t and AUC0-∞) were assessed for bioequivalence.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Dotilavir sodium tablet	The subjects randomly received single oral administration of Dotilavir sodium tablet 50mg.
DRUG	Dotilavir sodium tablet(Tivicay@)	The subjects randomly received single oral administration of Dotilavir sodium tablet 50mg.

Timeline

• Start date: 2021-12-01
• Primary completion: 2021-12-31
• Completion: 2022-01-31
• First posted: 2021-12-23
• Last updated: 2021-12-23

Locations

1 site across 1 country: China